First blood to Roche in Hemlibra patent fight with Shire

The new haemophilia drug does not infringe Baxalta’s patent, rules Tokyo court

Roche’s defence of its haemophilia drug Hemlibra against a patent infringement challenge by Shire has been buoyed by a Japanese ruling.

A Tokyo court has found in favour of the Swiss group and recommended that Shire’s challenge against majority-owned Japanese affiliate Chugai should be dismissed. While the ruling doesn’t have a direct bearing on additional challenges outside Japan, Roche has been buoyed by the result.

In a statement, the company said the court ruled that Hemlibra (emicizumab) “does not infringe patent 4313531, held by Shire’s wholly-owned subsidiaries Baxalta Inc and Baxalta GmbH”.

Hemlibra has been approved in the US, Europe and Japan to prevent or reduce the frequency of bleeding episodes in patients with haemophilia A who have developed inhibitors to Factor VIII. It is a first-in-class bispecific factor IXa- and factor X-directed antibody - delivered by subcutaneous injection once a week - and in trials has been shown to reduce the number of bleeding episodes in these patients as well as improve physical functioning.

With Hemlibra, Roche is trying to break into a market for haemophilia drugs worth around $7bn in the world's top seven markets (US, France, Germany, Italy, Spain, the UK and Japan) last year. The haemophilia A with inhibitors category is currently dominated by Shire and Novo Nordisk with its Feiba and NovoSeven bypassing agents (PBAs).

Approval of the drug came after a protracted battle with Shire which - along with allegations of patent infringement in the US filed in a Delaware district court - has also focused on what Shire claims was deliberate misinformation about its drugs made by Roche.

A ruling on the US patent battle could come later this year, according to Shire, which filed a motion for preliminary injunction against Roche and Chugai last December claiming that Hemlibra infringes its US patent 7,033,590.

At the time, Shire said it was “not seeking a blanket prohibition of emicizumab sales, but rather the request proposes a carve-out to enable those patients with the greatest need to continue to have access to the treatment”.

Analysts have suggested Hemlibra could eventually become a $1.5bn product at peak, eclipsing Shire’s inhibitor therapies, which made around $450m in sales last year.